Electric Wheelchair (Robooter E60) (BBR-E60-01); Electric Wheelchair (Robooter E60) (BBR-E60-02); Electric Wheelchair (Robooter E60) (BBR-E60-03); Electric Wheelchair (Robooter E60) (BBR-E60-04); Electric Wheelchair (Robooter E60) (BBR-E60-05); Electric Wheelchair (Robooter E60) (BBR-E60-06); Electric Wheelchair (Robooter E60) (BBR-E60-07); Electric Wheelchair (Robooter E60) (BBR-E60-08)

Q: What is the product code of K240339?

The FDA product code is ITI – Wheelchair, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.3860.

FDA 510(k) K240339 · Shanghai Bangbang Robotics Co., Ltd.

Substantially Equivalent

510(k) numberK240339

Submission

Device name: Electric Wheelchair (Robooter E60) (BBR-E60-01); Electric Wheelchair (Robooter E60) (BBR-E60-02); Electric Wheelchair (Robooter E60) (BBR-E60-03); Electric Wheelchair (Robooter E60) (BBR-E60-04); Electric Wheelchair (Robooter E60) (BBR-E60-05); Electric Wheelchair (Robooter E60) (BBR-E60-06); Electric Wheelchair (Robooter E60) (BBR-E60-07); Electric Wheelchair (Robooter E60) (BBR-E60-08)
Applicant: Shanghai Bangbang Robotics Co., Ltd.
Shanghai, CN
Received: February 5, 2024
Decision date: July 22, 2024
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: ITI – Wheelchair, Powered
Device class: Class II (moderate risk)
Regulation: 21 CFR 890.3860
Specialty: Physical Medicine

A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. FDA interprets mobility to persons restricted to a sitting position to mean the device type is intended to provide mobility to individuals who have mobility impairments and require an assistive device for mobility. NOTE: This type…

Other 510(k)s with product code ITI

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K260229	Electric wheelchair (HC819N, HC830N, HC831N)ITI · Traditional	Yongkang Hengyi Vehicle Co., Ltd.	09/08/2026SE
K260053	Power Wheelchair (OS-R-M01I)ITI · Traditional	Beijing OrionStar Technology Co., Ltd.	09/08/2026SE
K261354	Electric wheelchair (D03)ITI · Traditional	Foshan Sowell Medical Technology Co., Ltd.	08/21/2026SE
K261149	Electric Wheelchair (DY611A-2, DY612A-1)ITI · Traditional	Zhejiang Lumbre Electric Appliance Co., Ltd.	07/10/2026SE
K261396	Electric WheelchairITI · Traditional	Ningbo Resshidi Medical Devices Co., Ltd.	07/08/2026SE
K261164	Electric wheelchair (XW-LY007 )ITI · Traditional	Yongkang Ruihe Metal Product Co., Ltd.	07/07/2026SE
K260937	Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK)ITI · Traditional	Shanghai Waylong Intelligent Technology Co.,Ltd	06/24/2026SE
K253812	Power Wheelchair (W5915B, W5915C, W5915D)ITI · Traditional	Zhejiang Innuovo Rehabilitation Devices Co.,Ltd	06/18/2026SE
K260335	Electric Wheelchair (S500-6)ITI · Traditional	Zhongshan Sulenz Intelligent Technology Co., Ltd.	06/15/2026SE
K261175	WHILL (WHILL Model C2)ITI · Traditional	Whill, Inc.	06/12/2026SE

More from Whill, Inc.

510(k)	Device	Decision
K253276	Electric Wheelchair (Robooter E80) (BBR-E80-01); Electric Wheelchair (Robooter E80)…ITI · Special	01/15/2026SE
K231868	Electric Wheelchair (Robooter E40), Model name: BBR-E40-01ITI · Traditional	10/31/2023SE
K223393	Electric WheelchairITI · Traditional	03/16/2023SE

Questions and answers

When was Electric Wheelchair (Robooter E60) (BBR-E60-01); Electric Wheelchair (Robooter E60) (BBR-E60-02); Electric Wheelchair (Robooter E60) (BBR-E60-03); Electric Wheelchair (Robooter E60) (BBR-E60-04); Electric Wheelchair (Robooter E60) (BBR-E60-05); Electric Wheelchair (Robooter E60) (BBR-E60-06); Electric Wheelchair (Robooter E60) (BBR-E60-07); Electric Wheelchair (Robooter E60) (BBR-E60-08) cleared by the FDA?

Electric Wheelchair (Robooter E60) (BBR-E60-01); Electric Wheelchair (Robooter E60) (BBR-E60-02); Electric Wheelchair (Robooter E60) (BBR-E60-03); Electric Wheelchair (Robooter E60) (BBR-E60-04); Electric Wheelchair (Robooter E60) (BBR-E60-05); Electric Wheelchair (Robooter E60) (BBR-E60-06); Electric Wheelchair (Robooter E60) (BBR-E60-07); Electric Wheelchair (Robooter E60) (BBR-E60-08) (K240339) received a 510(k) decision of Substantially Equivalent on July 22, 2024, 168 days after the submission was received.

What is the product code of K240339?

The FDA product code is ITI – Wheelchair, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.3860.